Trial Outcomes & Findings for Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease (NCT NCT01284634)
NCT ID: NCT01284634
Last Updated: 2018-08-08
Results Overview
Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline to EOT (Day 57) or Early Termination (ET)
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
GWP42003 200 Milligram (mg)/Day Dose
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
7
|
5
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
7
|
6
|
7
|
5
|
|
Overall Study
Intent to Treat (ITT) Analysis Set
|
7
|
6
|
7
|
5
|
|
Overall Study
COMPLETED
|
6
|
6
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
GWP42003 200 Milligram (mg)/Day Dose
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
2
|
1
|
Baseline Characteristics
Study to Evaluate the Effect of GWP42003 on Liver Fat Levels in Participants With Fatty Liver Disease
Baseline characteristics by cohort
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=7 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.69 years
STANDARD_DEVIATION 14.62 • n=5 Participants
|
49.08 years
STANDARD_DEVIATION 7.72 • n=7 Participants
|
46.90 years
STANDARD_DEVIATION 12.57 • n=5 Participants
|
50.41 years
STANDARD_DEVIATION 18.41 • n=4 Participants
|
46.39 years
STANDARD_DEVIATION 13.29 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline to EOT (Day 57) or Early Termination (ET)Population: ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
Liver triglyceride levels were measured by Magnetic Resonance Imaging/Magnetic Resonance Scanning and the percent change from baseline to EOT in group mean levels was investigated. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Outcome measures
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=6 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Percent Change From Baseline To The End Of Treatment (EOT) In Mean Liver Triglyceride Levels
|
-0.68 percentage change
Standard Deviation 4.97
|
-0.28 percentage change
Standard Deviation 8.60
|
0.65 percentage change
Standard Deviation 5.28
|
6.36 percentage change
Standard Deviation 17.97
|
SECONDARY outcome
Timeframe: Baseline to EOT (Day 57) or ETPopulation: ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
A fasting blood sample was taken for the measurement of serum total cholesterol. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Outcome measures
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=7 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Change From Baseline To The EOT In Mean Serum Total Cholesterol Levels
|
0.07 millimole (mmol)/l
Standard Deviation 0.76
|
0.03 millimole (mmol)/l
Standard Deviation 0.51
|
-0.14 millimole (mmol)/l
Standard Deviation 0.31
|
-0.62 millimole (mmol)/l
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline to EOT (Day 57) or ETPopulation: ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
A fasting blood sample was obtained for the measurement of HDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Outcome measures
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=7 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Change From Baseline To The EOT In Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
|
0.07 mmol/l
Standard Deviation 0.15
|
0.08 mmol/l
Standard Deviation 0.15
|
0.06 mmol/l
Standard Deviation 0.17
|
-0.14 mmol/l
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline to EOT (Day 57) or ETPopulation: ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
A fasting blood sample was obtained for the measurement of LDL-C. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Outcome measures
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=7 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Change From Baseline To The EOT In Mean Serum Low-Density Lipoprotein (LDL)-C Levels
|
0.11 mmol/l
Standard Deviation 0.631
|
0.08 mmol/l
Standard Deviation 0.407
|
0.00 mmol/l
Standard Deviation 0.432
|
-0.34 mmol/l
Standard Deviation 0.737
|
SECONDARY outcome
Timeframe: Baseline to EOT (Day 57) or ETPopulation: ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
A fasting blood sample was obtained for the measurement of HDL-C and LDL-C, allowing the HDL:LDL cholesterol ratio to be calculated. An increase from baseline, that is, a positive value, indicates an improvement in condition.
Outcome measures
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=7 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Change From Baseline To The EOT In Mean Serum HDL: Low Density Lipoprotein (LDL)-Cholesterol (C) Ratio
|
-0.02 change in ratio
Standard Deviation 0.13
|
-0.00 change in ratio
Standard Deviation 0.08
|
0.03 change in ratio
Standard Deviation 0.09
|
0.01 change in ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline to EOT (Day 57) or ETPopulation: ITT analysis set: All participants who were randomized, received at least one dose of study medication, and had on-treatment efficacy data. Participants who did not have any relevant post-randomization efficacy data were excluded from the analysis.
A fasting blood sample was obtained for the measurement of serum triglycerides. A reduction from baseline, that is, a negative value, indicates an improvement in condition.
Outcome measures
| Measure |
GWP42003 200 mg/Day Dose
n=7 Participants
Participants self-administered one 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 Participants
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 800 mg/Day Dose
n=7 Participants
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 Participants
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Change From Baseline To The EOT In Mean Serum Triglyceride Levels
|
-0.40 mmol/l
Standard Deviation 1.05
|
-0.29 mmol/l
Standard Deviation 0.82
|
-0.50 mmol/l
Standard Deviation 1.16
|
-0.28 mmol/l
Standard Deviation 0.39
|
Adverse Events
GWP42003 200 mg/Day Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GWP42003 400 mg/Day Dose
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
800 mg GWP42003
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
GWP42003 200 mg/Day Dose
n=7 participants at risk
Participants self-administered one x 100 mg GWP42003 capsule twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
GWP42003 400 mg/Day Dose
n=6 participants at risk
Participants self-administered two x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
800 mg GWP42003
n=7 participants at risk
Participants self-administered four x 100 mg GWP42003 capsules twice daily for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
Placebo
n=5 participants at risk
Participants self-administered one, two or four placebo capsules twice daily, for 8 weeks (the first dose was 30 minutes before breakfast \[fasted\] and the second was 30 minutes before the evening meal \[typically 12 hours apart\]).
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Ear and labyrinth disorders
Meniere's disease
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Abnormal faeces
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Change of bowel habit
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Defaecation urgency
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
57.1%
4/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
50.0%
3/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
71.4%
5/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
General disorders
Fatigue
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
General disorders
Product size issue
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Investigations
Heart sounds abnormal
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
50.0%
3/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
28.6%
2/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
20.0%
1/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
16.7%
1/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/6 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
14.3%
1/7 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
0.00%
0/5 • Day 1 through Day 77
Safety analysis set: All randomized participants who received at least one dose of IMP were included and analyzed according to the treatment received.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER